Salofalk Dosage/Direction for Use

Posology: Gastro-resistant tablet: Adults and elderly: Depending upon the clinical requirements in the individual case, the following daily dosages are recommended: (See Table 1.)

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Gastro-resistant tablet and PR granules: Children: There is only limited documentation for an effect in children (age 6-18 years).
Children 6 years of age and older: Active disease: To be determined individually, starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day. The total dose should not exceed the maximum adult dose.
Maintenance treatment (ulcerative colitis): To be determined individually, starting with 15-30 mg/kg/day in divided doses. The total dose should not exceed the recommended adult dose.
It is generally recommended that half the adult dose may be given to children up to a body weight of 40 kg; and the normal adult dose to those above 40 kg.
PR granules: Adults and the elderly: For the treatment of acute episodes of ulcerative colitis: Once daily, 1 sachet of Salofalk 3g granules, 1-2 sachets of Salofalk 1.5g granules, 3 sachets of Salofalk 1000mg granules or 3 sachets of Salofalk 500mg granules (equivalent to 1.5-3.0 g mesalazine daily) preferably to be taken in the morning according to the individual clinical requirement.
It is also possible to take the prescribed daily dose in three divided doses (1 sachet of Salofalk 500mg granules 3 times daily or 1 sachet of Salofalk 1000mg granules 3 times daily) if this is more convenient to the patient.
For the maintenance of remission of ulcerative colitis: The standard treatment is 0.5 g mesalazine 3 times daily (in the morning, at midday and in the evening) corresponding to a total dose of 1.5 g mesalazine per day.
For patients known to be at increased risk for relapse for medical reasons or due to difficulties to adhere to application of three daily doses, the dosing schedule can be adapted to 3.0 g mesalazine given as a single daily dose, preferably in the morning.
Suppository: Insert 1 Salofalk 500 mg suppository into the anus in the morning, at midday and in the evening when acute signs of inflammation are present.
As soon as remission occurs, the dose should be reduced to 1 suppository of Salofalk 250 mg 3 times daily to avoid recurrences.
Treatment with Salofalk 500 mg suppositories demands reliability and consistency from the side of the patient to enable therapeutic success.
The duration of therapy is determined by the physician.
Enema: (Salofalk 2g/30ml enemas): Adults and elderly: In patients with symptoms of acute inflammation, the content of two enema bottles (2 x 30 g suspension) is instilled in the rectum as an enema once daily at bedtime.
Children: There is little experience and only limited documentation for an effect in children.
If there are problems to retain the large quantity of liquid, the Salofalk 2g/30ml enemas may also be applicated in two doses, e.g. during the night (after a bowel movement which discharges the first doses) or early in the morning.
Treatment with Salofalk enemas must be administered regularly and consistently, because only in this way can healing be successfully achieved.
Method of administration: The duration of use is determined by the physician.
Gastro-resistant tablet: Salofalk 500mg tablets should be taken in the morning, at midday and in the evening, 1 hour before meals. They should be swallowed whole, not chewed, and taken with plenty of fluid.
Treatment with Salofalk 500mg tablets should be administered regularly and consistently, both in the acute inflammatory stage and during maintenance therapy in order to achieve the desired therapeutic effect.
For maintenance of remission in ulcerative colitis, the dose can usually be reduced to 1.5 g mesalazine/day (adults and adolescents with a body weight over 40 kg) and 0.75 g mesalazine/day (children/adolescents).
Granules: The contents of the sachets of Salofalk granules should not be chewed.
The granules should be taken on the tongue and swallowed, without chewing, with plenty of liquid.
Both in the treatment of acute inflammatory episodes and during long term treatment, Salofalk granules should be used on a regular basis and consistently in order to achieve the desired therapeutic effects.
This product is not interchangeable with other brand or dosage form of products containing mesalazine.
Enema: Rectal use.
The best results are achieved if the bowel is emptied before administration of the Salofalk enemas.
Preparation: The bottle should be shaken for 30 seconds.
Then the protective cap of the applicator removed.
The bottle should be held at the top and the bottom.
The correct position for administration is as follows: The patient should lie down on his/her left side with his/her left leg stretched out and right leg bent. This makes it easier for the rectal suspension to be administered and for the enema to be effective.
Administration of the rectal suspension: The tip of the applicator should be inserted deep into the rectum.
The bottle should be tipped downwards slightly and then squeezed slowly.
Once the bottle is empty, the applicator tip should be slowly withdrawn from the rectum.
The patient should remain lying down in this position for at least 30 minutes to allow the contents of the enema to spread throughout the rectum.
If possible, the rectal suspension should be allowed to exert its effects all night.